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Speed Can Kill: In Biotech Too!

Our industry is obsessed with speed to first in human trials. We all know the mantra – push to make the “first in man” milestone at all cost. This driver has caused companies to seek FDA’s Fast-Track designation for their development projects. Since July 2012, 516 projects have been granted...

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Keys to faster development pathways

Compressing the mammalian cell culture development timeline CBI / UBM Life Sciences recently launched their new bioprocessing conference series with a two-day event in San Francisco entitled “Speed to IND for Biologics”, focusing specifically on “Integration of Novel Technologies. Strategies and Cross-Functional Approaches to Accelerate Development and Compress Timelines”. Industry experts...

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HER2: Teaching an Old Target New Tricks

It’s all in the target. The HER2 story shows that a great target can spur development of numerous successful drugs and drive innovation over decades. Products that bind HER2 have been associated with numerous innovations in biotechnology, including mouse antibody humanization, precision medicine, bispecific antibodies, ADCs, biosimilars and ADCC modification. HER2 had...

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The Other CAR-T Race: Manufacturing

The biosphere is still buzzing about the FDA’s approval of Kymriah – Novartis’ CAR-T treatment for acute lymphoblastic leukemia that, in many ways, marks the true beginning of the cell and gene therapy era. Approvals of other CAR-Ts are expected soon. But behind the scenes, there’s another race going on:...

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Cheaper Vaccines! Maybe?

I came away from this year’s World Vaccine Congress impressed by two potentially revolutionary technologies that could radically change the cost of vaccines. The first technology, from LimmaTech Biologics AG, is a manufacturing process for producing conjugate vaccines that eliminates the conjugation chemistry steps and further downstream purification by combining the...

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